Osimertinib(Tagrisso)

In November 2015, a prescription medicine targeting mutations in the epidermal growth factor receptor (EGFR) gene, particularly the T790M mutation, received its first accelerated approval from the U.S. Food and Drug Administration (FDA) and should be used strictly under medical supervision.

Target

Mutations of the epidermal growth factor receptor (EGFR) gene (especially the T790M mutation).

Mechanism of Action

Tagrisso is designed to inhibit sensitizing mutations of the epidermal growth factor receptor (exon 19 deletions and exon 21 L858R mutation) and the acquired resistance mutation (EGFR T790M)¹⁻⁴.

Dosage and Administration

Route and frequency of administration of Osimertinib: Oral administration, once daily, 80 mg each time.

The specific dosage should be prescribed and supervised by a doctor.

Recommended reading: Dosage and Administration of Osimertinib

Adverse Reactions

Common side effects: Low white blood cell count, low platelet count, low red blood cell count (anaemia), etc.

Serious side effects: Lung problems, heart problems, eye problems, etc.

Reference article: Side Effects of Osimertinib

Use in Special Populations

Pregnancy:

Osimertinib may cause harm to your unborn baby. If you become pregnant or think you may be pregnant during treatment with osimertinib, tell your healthcare provider immediately.

Lactation:

It is not known whether osimertinib is excreted in human milk. Do not breastfeed during treatment with osimertinib and for 2 weeks after the last dose. Discuss with your healthcare provider the best infant feeding practices during this period.

Daily Precautions

1. There is a risk of severe or fatal interstitial lung disease / pneumonitis.

Patients should be strongly advised to immediately inform their healthcare provider if new or worsening respiratory symptoms occur (e.g., dyspnoea, shortness of breath, cough, fever).

2. There is a risk of QTc interval prolongation.

Patients should be strongly advised to immediately inform their healthcare provider if any suspected symptoms of QTc interval prolongation occur (e.g., dizziness, light-headedness, syncope).

3. There is a risk of cardiomyopathy.

Patients should be strongly advised to immediately inform their healthcare provider if manifestations of heart failure occur (e.g., palpitations, shortness of breath, oedema).

from FDA，2022.10